Brian Mccole Email and Phone Number
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Brian Mccole personal email
Highly experienced professional with a record of developing and supporting successful projects focused on the business processes improvement and governance of supporting technologies, in the Life Sciences industry. Consistently recognized by management as an excellent resource to improve organizational effectiveness, remediate noncompliance, and provide clear, logical and defensible compliance positions. Regulatory savvy and a quick study in emerging techniques, able to quickly assess and utilize the appropriate response to meet the specific needs of the business and quality compliance requirements at hand.Specialties: SME - CAPA and Quality System • 21 CFR Part 11 Assessments • Computer System Validation • ERP/MES Nonconformance Remediation • Project Management • Governance, Risk Management and Compliance • Process Improvement Lead • Team Leadership • Compliance Training • Quality Auditor (CQA) • Supply Chain and Materials Management (CPIM) • Lean Six Sigma • TrackWise
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Qms Practice DirectorUsdm Life Sciences Jan 2014 - PresentGreater Philadelphia AreaUSDM is changing how compliance is addressed for life science companies worldwide. We are committed to achieving both PERFORMANCE and COMPLIANCE from the systems that run life sciences organizations. We partner with technology vendors who lead in the life sciences sector, assimilate the technology into a adaptable model and support the proper implementation and maintenance of such systems. Our partners include Agilent, Oracle and SAP as well as many others. Our clients include emerging biotechnology companies as well as the largest pharmaceutical players. Our team grows as quickly as we can find the rare people who can support our mission with the same passion and capability. -
Vice President, Quality InitiativesUsdm Life Sciences Jan 2014 - PresentPhiladelphia, PaWorking with the Life Sciences industry to realize quality initiatives and compliance advancements ...
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Director, Quality Systems & ValidationIgate 2006 - Jan 2014Subject Matter Expert - Quality & Enterprise Compliance at iGATE-Patni (formerly Taratec). -
Principal ConsultantMccole & Associates, Inc. 2003 - 2006Quality consulting practice focused on the design, implementation, and valiidation of Quality Systems for ISO and GxP quality-regulated clients.
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Lead Compliance ConsultantIves Envision 2000 - 2002Program Manager for a global CSV/Part-11 remediation program as a response to client's Consent Decree. Managed the activities of 60+ consultants andc 100 GxP systems.
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Manager, Erp Consulting & ValidationSap/Baan/Ssa/Cincom 1985 - 2000Managed ERP system implementations and validation projects for quality-related industures (i.e., GxP, ISO, Aerospace/Defense).
Brian Mccole Skills
Brian Mccole Education Details
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Operations Management
Frequently Asked Questions about Brian Mccole
What company does Brian Mccole work for?
Brian Mccole works for Usdm Life Sciences
What is Brian Mccole's role at the current company?
Brian Mccole's current role is Vice President, Quality Initiatives at USDM Life Sciences.
What is Brian Mccole's email address?
Brian Mccole's email address is br****@****zon.net
What schools did Brian Mccole attend?
Brian Mccole attended Villanova University.
What skills is Brian Mccole known for?
Brian Mccole has skills like 21 Cfr Part 11, Quality System, Computer System Validation, Capa, Validation, Fda, Gxp, Quality Auditing, Process Improvement, Quality Assurance, Gamp, Change Control.
Who are Brian Mccole's colleagues?
Brian Mccole's colleagues are Tisha Piercey, Brett Malikowski, Mirian Mestari, Danelle O'donnell, Nithya Sittaramane Ms, Mba, Stefka Tzoneva, Kim Guihen.
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Brian Mccole
Bryn Mawr, Pa2gmail.com, taratec.com -
Brian McCole
Spring, Tx3aol.com, npsdover.com, flowcosolutions.com -
Brian McCole
Greater Philadelphia5hotmail.com, therockschool.net, therockschool.org, therockschool.org, elliottlewis.com1 +121555XXXXX
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